Systems and methods for reshaping a heart valve

ABSTRACT

The present disclosure includes a device for reshaping a heart valve. The device may include a central ring about a central axis and a plurality of arms coupled to the central ring, each of the arms coupled to the central ring at a pivot point at a first end of the arm, the arm comprising an attachment feature at a second point along the arm, the pivot point configured to allow movement of the arm about the pivot point through a plane extending radially from the central axis through the arm. Additionally, the plurality of arms may be contractable and may be extendable such that the hooks extend beyond a dilated heart valve. The present disclosure also includes associated methods and systems.

PRIORITY INFORMATION

The present application claims priority under 35 U.S.C. § 119(e) to U.S.Provisional Patent Application Ser. No. 61/783,420, filed Mar. 14, 2013and incorporated by reference herein.

TECHNICAL FIELD OF THE INVENTION

The present disclosure relates generally to heart treatment devices andmethods, and more particularly, to systems and methods for reshaping aheart valve.

BACKGROUND

The present disclosure addresses heart valve incompetency. For example,heart disease can cause the chambers of the heart to expand and weaken.With specific reference to the mitral valve, as the left ventricledilates, the papillary muscles are displaced. Consequently, the annulusof the mitral heart valve dilates, excessively. In this state ofdilation, valve leaflets no longer effectively close, or coapt, duringsystolic contraction. Consequently, regurgitation of blood occurs duringventricular contraction and cardiac output is decreased.

This condition is typically addressed by open-heart surgicalimplantation of an annuloplasty ring. A surgeon positions theannuloplasty ring proximate the valve annulus and sutures it in placethereby restoring the valve annulus to approximately its nativecircumference. The valve leaflets can then function normally again.

SUMMARY

In one embodiment, the present disclosure includes a device forreshaping a heart valve comprising a central ring about a central axisand a plurality of arms coupled to the central ring, each of the armscoupled to the central ring at a pivot point at a first end of the arm,the arm comprising an attachment feature at a second point along thearm, the pivot point configured to allow movement of the arm about thepivot point through a plane extending radially from the central axisthrough the arm. In this embodiment, the plurality of arms arecontractable and are extendable such that the attachment features extendbeyond a dilated heart valve.

In another embodiment, the present disclosure includes a method forreshaping a heart valve comprising deploying a device, the devicecomprising a central ring about a central axis and a plurality of armscoupled to the central ring, each of the arms coupled to the centralring at a pivot point at a first end of the arm, the arm comprising anattachment feature at a second point along the arm, the pivot pointconfigured to allow movement of the arm about the pivot point through aplane extending radially from the central axis through the arm. Themethod also includes extending the plurality of arms beyond a dilatedheart valve and engaging the attachment features into tissue proximatethe dilated heart valve. The method additionally includes contractingthe plurality of arms to reduce the circumference of the dilated heartvalve.

In an additional embodiment, the present disclosure includes a systemcomprising a delivery catheter and a delivery shaft disposed within thedelivery catheter. The system also includes a device for delivery by thedelivery catheter and removably coupled to the delivery shaft. Thedevice comprises a central ring about a central axis, and a plurality ofarms coupled to the central ring, each of the arms coupled to thecentral ring at a pivot point at a first end of the arm, the armcomprising an attachment feature at a second point along the arm, thepivot point configured to allow movement of the arm about the pivotpoint through a plane extending radially from the central axis throughthe arm. In such an embodiment, the plurality of arms are contractableand are extendable such that the attachment features extend beyond adilated heart valve.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding of the present disclosure and itsfeatures and advantages, reference is now made to the followingdescription, taken in conjunction with the accompanying drawings, inwhich:

FIGS. 1A through 1D illustrate an example of a device for reshaping aheart valve, in accordance with some embodiments of the presentdisclosure;

FIGS. 2A and 2B illustrate an example embodiment of reshaping a heartvalve using a device, in accordance with some embodiments of the presentdisclosure;

FIG. 3 illustrates an example of a delivery system for delivery of adevice for reshaping a valve, in accordance with some embodiments of thepresent disclosure;

FIGS. 4A-4F illustrate an example of expanding a device, in accordancewith some embodiments of the present disclosure;

FIGS. 5A and 5B illustrate an example of utilizing an engaging member,in accordance with some embodiments of the present disclosure;

FIGS. 6A-6D illustrate an example embodiment of a device for reshaping aheart valve;

FIGS. 7A-7D illustrate an example of operation of an example hook, inaccordance with some embodiments of the present disclosure; and

FIGS. 8A-8D illustrate an example of operation of another example hook,in accordance with some embodiments of the present disclosure.

DETAILED DESCRIPTION

The present disclosure addresses systems and methods for reshaping aheart valve. A device with a plurality of arms coupled to a central ringmay be utilized to reshape a heart valve. The device may pivot about oneend of the arms, which may be coupled to the central ring. At a secondpoint along a respective arm (for example, the opposite end from thepivot point), there may be a hook or some other attachment feature. Anarm may have its pivoting motion limited to the plane extending radiallyfrom a central axis of the ring through the arm. The device may alsoinclude a slider with linkages between the slider and the arms. Thus,the action of the device may resemble that of a parasol as the slider isslid along the central axis of the central ring to cause the arms of thedevice to extend or contract. To reshape the heart valve, the device maybe deployed proximate the valve annulus. The arms may be extended (forexample, like a parasol opening) beyond the annulus or beyond a diseasedor dilated heart valve and then the hooks at the end of the arms may beengaged with the tissue, for example, by pulling the device down againstthe valve with the arms extended. Once the hooks are engaged, the armsmay be contracted (for example, like a parasol closing). With the hooksengaged in the tissue, the contracting arms may draw the annular tissueinwards as they are contracted such that the valve leaflets coapt moreappropriately by decreasing the circumference of the valve annulus orthe area of the valve opening. The device may then be caused to retainits contracted shape.

FIGS. 1A and 1B illustrate an example of a device 100 for reshaping aheart valve, in accordance with some embodiments of the presentdisclosure. FIG. 1A illustrates a perspective view and FIG. 1Billustrates a top-down view of device 100. Device 100 may include acentral ring 110 with a plurality of arms 120 coupled to central ring110. For reference, a central axis 130 may pass through the center ofcentral ring 110 and be perpendicular to the plane of central ring 110.Device 100 may further include a slider 140, which is slidable alongcentral axis 130 and linkages 150, which are coupled to slider 140 andto arms 120. Device 100 may be made of any suitable biocompatible metalor high strength polymer such as stainless steel, cobalt chromium,nitinol, titanium, platinum, platinum/iridium, high molecular weightpolyethylene or polyurethane, or any other biocompatible material as isknown in the art.

Each arm 120 may be coupled to central ring 110 at a pivot point 160.Device 100 may be expanded or contracted by extending or contractingarms 120 about their respective pivot points 160. In some embodiments,the motion of arms 120 may be limited to essentially motion along theplane extending radially from central axis 130 to a particular arm 120.For example, the coupling between a given arm 120 and central ring 110may limit this motion as the coupling may be a hinge, an eye socket onarm 120 at pivot point 160, or some other mechanism as known in the artto facilitate motion limited about a pivot point. The motion of each armmay be independent, or some or all of the arms may be movedsimultaneously.

The motion of extending or contracting arms 120 about pivot point 160may be facilitated using slider 140 and linkages 150. By way of example,when slider 140 is at a position away from central ring 110, arms 120may be in a more contracted position. When slider 140 is slid alongcentral axis 130 from an initial position away from central ring 110 andtowards central ring 110, linkages 150 may push arms 120 radiallyoutward from central axis 130, extending arms 120 of device 100. In thereverse, when slider 140 is slid along central axis 130 from a positionproximate central ring 110 away from central ring 110, linkages 150 maypull arms 120 in towards central axis 130, contracting arms 120 ofdevice 100. By way of example and in no way meant to be limiting, thismotion using slider 140 and linkages 150 may be similar conceptually tothat observed in a parasol in which a slider may be used to open andclose the parasol. In some embodiments, linkages 150 may comprise morethan one piece. For example, linkages 150 may include two componentsthat are coupled by a hinge joint, or two components that slide pasteach other.

FIGS. 1C and 1D illustrate an example perspective view (FIG. 1C) andtop-down view (FIG. 1D) of device 100 when its arms 120 are extended. Asshown in FIGS. 1C and 1D, as slider 140 is moved closer to central ring110, linkages 150 may force arms 120 to extend radially outward fromcentral ring 110.

In some embodiments, linkages 150 may include a hinge joint at each end.In other words, linkage may have a hinge at both slider 140 and arm 120.Linkages 150 may also simply rely on the flexion of a rigid body toaccomplish the parasol-like motion of arms 120. For example, if linkages150 are fixed to slider 140 and unattached to arms 120, as slider 140 ismoved closer to central ring 110, linkages 150 may force arms 120 toextend. If arms 120 were biased towards a closed position (for exampleusing springs or a memory shaped material) or if arms 120 are coupled tolinkage 150 with a hinge joint, when slider 140 is moved away fromcentral ring 110, arms 120 would contract. It will be appreciated thatthese are merely examples of implementations of the parasol-like motion,and any similar expansion or contraction supported by a slider andlinkages would be within the scope of the present disclosure.

On the opposite end of arms 120 from pivot point 160 may be one or morehooks 170. Hooks 170 may be designed and shaped to pierce and engageannular tissue. In some embodiments, hooks 170 may be a tapered point ofarm 120. Hooks 170 may also be an angled and tapered point of arm 120.For example, hooks 170 may be angled at between approximately forty-fivedegrees and ninety degrees relative to the annular tissue when arms 120are fully extended, although these are merely examples and any anglethat facilitates hooks 170 piercing and engaging the annular tissuewould be within the present disclosure. The angled orientation of hooks170 to the annular heart tissue may reduce the force needed to piercethe annular tissue.

As will be appreciated, as device 100 is contracted by contracting arms112, the orientation of hooks 170 may also change. As their orientationchanges, hooks 170 may transition from perpendicular to the annulartissue to facilitate piercing the tissue, to an angled orientation forscooping tissue or drawing tissue towards central axis 130. This inwardorientation may be angled such that it opposes the forces and movementof the surrounding annular tissue and heart structures. In someembodiments, hooks 170 may be oriented differently with respect to eachother such that, overall, they are resisting forces, in multiplevectors, that might tend to extract or dislodge hooks 170. This may bebeneficial due to the continuous beating of the heart, generatingdiverse directions of forces on device 100, which might otherwisedislodge device 100.

FIGS. 2A and 2B illustrate an example embodiment of reshaping a heartvalve using a device, in accordance with some embodiments of the presentdisclosure. FIGS. 2A and 2B will be described with reference to device100 of FIGS. 1A-1D. Once device 100 has been deployed to a desiredlocation, for example, a left atrium with a dilated valve, device 100may be expanded by extending arms 120 of device 100. As described aboveand by way of non-limiting example, this motion may be analogous to aparasol opening. Once extended beyond the dilated valve annulus, a forcemay be applied to engage hooks 170 with the annular tissue. For example,as shown in FIG. 2A, device 100 has hooks 170 which have been engaged inannular tissue.

With hooks 170 engaged in annular tissue, device 100 may be contractedsuch that hooks 170 draw the annular tissue with them to reduce thecircumference or area of the valve opening. This may, for example,reduce or lessen mitral regurgitation. As described above and by way ofnon-limiting example, this motion may be analogous to a parasol closing.For example, as shown in FIG. 2B, hooks 170 are engaged with the tissueand arms 120 have contracted, drawing the valve leaflets closertogether. The action of hooks 170 when contracting arms 120 may also bedescribed as gathering or pushing the heart tissue surrounding the valveinwardly. The circumference of the annulus or valve area may thus bereduced such that the valve leaflets coapt normally and regurgitation isreduced. In some embodiments, regurgitation may be completelyeliminated.

FIG. 3 illustrates an example of a delivery system for delivery of adevice for reshaping a valve. As shown in FIG. 3 , a delivery system 300may include a delivery catheter 310, a delivery shaft 320, and a device100 for reshaping a valve.

Delivery catheter 310 may be any catheter with sufficient circumferenceto carry device 100 and delivery shaft 320. Delivery catheter 310 may beintroduced using any known method or route to arrive at the desiredchamber of the heart. For example, delivery catheter 310 may be routedtransapically, transseptally from the right atrium, or through thefemoral artery over the aortic arch and through the left ventricle.Still another entry may be directed through the left atrium.

Delivery shaft 320 may be removably coupled to device 100. For example,after deployment in the heart tissue and retraction of device 100,delivery shaft 320 may be decoupled from device 100, for example, bydisengaging or unthreading, leaving device 100 behind as a permanentimplant. Device 100 thus may also include corresponding threads,couplings, sockets, or other connecting features to allow device 100 tobe removably coupled with delivery shaft 320.

A typical delivery process may include using a guidewire to navigate thebody as described above to the desired chamber of the heart, forexample, the left atrium. Delivery catheter 310 may then be fed down theguidewire to the desired chamber. Delivery shaft 320 may then be guideddown delivery catheter 310 and into the desired chamber either passivelyby the guidewire or actively by steering means from outside the patientvia control handle. The controls may include push-pull wire mechanismand or rotational controls or the catheters or sheaths for accuratedelivery. At this point, delivery catheter 310 may be partiallywithdrawn or delivery shaft 320 may be extended beyond delivery catheter310 such that device 100 is no longer constrained within deliverycatheter 310.

FIGS. 4A-4C illustrate a side view of an example of expanding a device,and FIGS. 4D-4F illustrate corresponding top views of an example ofexpanding a device, in accordance with some embodiments of the presentdisclosure. With reference to FIGS. 4A-4F, once no longer constrainedwithin delivery catheter 310 shown in FIG. 3 , device 100 may beexpanded by extending arms 120 of device 100. This may be accomplished,for example, by sliding slider 140 along central axis 130 from alocation at its maximum distance from central ring 110 (for example asshown in FIGS. 4A and 4D) to a position proximate central ring 110 (forexample progressing from the positions shown in FIGS. 4A and 4D to thatshown in FIGS. 4B and 4E and ultimately to that shown in FIGS. 4C and4F). Slider 140 may be configured to slide along delivery shaft 320.This may be done by a tool within delivery catheter 310 able to moverelative to delivery shaft 320 to force slider 140 along delivery shaft320. As described above and by way of non-limiting example, this motionmay be analogous to a parasol opening.

Once expanded beyond a dilated valve annulus, a force may be applied viathe delivery shaft 320 to engage hooks 170 with the annular tissue. Onceengaged, device 100 may be contracted, hooks 170 drawing the annulartissue with them to reduce the circumference of the valve. This may beaccomplished, for example, by sliding slider 140 along central axis 130from a location proximate central ring 110 (for example, as shown inFIGS. 4C and 4F) to a location further away from central ring 110 (forexample, that shown in FIGS. 4B and 4E). This may be done by slidingslider 140 along delivery shaft 320. As described above and by way ofnon-limiting example, this motion may be analogous to a parasol closing.

Depending on the delivery path, delivery catheter 310 may be approachingthe valve from above the valve (e.g. from within the atrium) or may beapproaching the valve from beneath the valve (e.g. from within theventricle, through the valve and into the atrium). When approaching fromabove the valve, a force may be generated to engage hooks 170 with theannular tissue by pushing on delivery shaft 320. This may then bepushing device 100 and thus hooks 170 into the annular tissue. Whenapproaching from below the valve, a force may be generated to engagehooks 170 with the annular tissue by pulling on delivery shaft 320. Thismay then pull device 100 and thus hooks 170 into the annular tissue.

FIGS. 5A and 5B illustrate an example of utilizing an engaging member,in accordance with some embodiments of the present disclosure. Forexample, FIG. 5A illustrates device 100 with hooks 170 engaged withannular tissue. Further, as shown in FIG. 5A, arms 120 are contracteddown a certain amount such that the circumference of the valve has beenreduced. In some embodiments of the present disclosure, an engagingmember may be utilized to prevent arms 120 from extending beyond adesired size. The present disclosure contemplates any mechanism employedor component coupled to device 100 to maintain arms 120 in a contractedstate. One non-limiting, illustrative example of such an engaging memberis a ring like that illustrated in FIG. 5B.

FIG. 5B illustrates a ring 510 that may be slid over the top of device100 to engage arms 120 to maintain device 100 in the contracted state.By maintaining arms 120 of device 100 in a contracted state, the dilatedvalve may also be maintained in a reduced circumference. Placing ring510 over the top of device 100 and sliding it down arms 120 of device100 may further contract arms 120 by applying a force to the outside ofarms 120, where slider 140 and linkages 150 of FIGS. 1A-1D applied aforce to the inside of arms 120. In some embodiments, arms 120 may havea groove or notch on the outside for ring 510 to settle in once ring 510has been slid down the outside of arms 120 a desired distance. Ring 510may be made of any biocompatible material, for example, metal, metalalloy, plastic, elastomer, or other biocompatible materials as known inthe art. In addition to ring 510, other engaging members may be used tomaintain arms 120 of device 100 in a contracted state.

FIGS. 6A-6D illustrate an example embodiment of a device 600 forreshaping a heart valve. As shown in FIG. 6A, in some embodiments,device 600 may include a central ring 610, arms 620 coupled to centralring 610, and hooks 670 at the end of arms 620. For reference, a centralaxis 630 may pass through the center of central ring 610 and beperpendicular to the plane of central ring 610. In the embodiment shownin FIGS. 6A-6D, an alternative mechanism is used to extend and contractaims 620 of device 600 when compared with the mechanism described withrespect to FIGS. 1A-1D. While arms 620 follow a similar path of motionas that described with respect to device 100 of FIGS. 1A-1D, device 600does not use a slider or linkage system similar to that illustrated inFIGS. 1A-1D. For example, the motion of arms 620 may be limited toessentially motion along the plane extending radially from central axis630 to a particular arm 620.

In some embodiments, the force to contract arms 620 may be derived byusing a shape memory material, for example nitinol. For example, device600 may have a memory configuration of a contracted state such thatdevice 600 may be deployed or deformed to a particular state and, atbody temperature, will transform back to the contracted state. This maybe a completely contracted state, for example one in which arms 620 aresubstantially parallel with central axis 630, or may be only partiallycontracted, for example one in which arms 620 are at some acute angle(for example between zero and sixty degrees) with central axis 630.

To provide the expansive force to extend arms 620 of device 600, adelivery catheter 650 may utilize a balloon 652. For example, whendeploying device 600, balloon 652 may be disposed between arms 620 anddelivery shaft 650. When device 600 has been disposed within the desiredlocation (e.g. the left atrium), balloon 652 may be inflated to causearms 620 to extend outward against the inwardly biased memory shape ofdevice 600. For example, when comparing FIG. 6A to FIG. 6B, balloon 655is inflated causing arms 620 to be extended.

In some embodiments, the expansion caused by inflation of balloon 655may not be only about the point where arms 620 couple with central ring610. For example, a portion of the displacement of arms 620 caused byballoon 655 may be bowing or bending of arms 620.

In some embodiments, a cap 680 may be used to limit the expansion ofarms 620 based on the inflation of balloon 652. For example, cap 680 mayprevent arms 620 from extending beyond approximately perpendicular tocentral axis 630. Cap 680 may be part of device 600 or may be a separatecomponent that may be deployed with delivery shaft 650 and removed uponcontraction of arms 620.

With this embodiment in mind, as shown in FIG. 6B, balloon 655 may beinflated to extend arms 620 beyond their shape memory state. In thisextended state, a force may be applied to cause hooks 670 to engage theannular tissue. As shown in FIG. 6C, once the hooks have engaged theannular tissue, balloon 655 may be deflated. As balloon 655 is deflatedthe shape memory characteristics of device 600 cause arms 620 tocontract back to their shape memory state. As this occurs, hooks 670,which are engaged in the annular tissue, draw the annular tissue alongwith them causing a decrease in the circumference of the valve. Statedanother way, as arms 620 contract back to their shape memory state,hooks 670 gather or push the heart tissue surrounding the annulus orvalve area inwardly.

Once balloon 655 has been sufficiently deflated, delivery shaft 650 andballoon 655 may be withdrawn such that device 600 remains as a permanentimplant to maintain the reduced circumference of the heart valve. Inembodiments where cap 680 is a separate component, it may also beretrieved and withdrawn at the same time that delivery shaft 650 andballoon 655 are withdrawn. This may leave device 600 in a finalconfiguration as a permanent implant, for example, as shown in FIG. 6D.

In some embodiments, central ring 610 and arms 620 may be a unitary bodyof shape memory material. Alternatively, arms 620 may be shape memorymaterial and coupled to central ring 610 as a separate component. Insome embodiments, multiple arms 620 may be a unitary body coupled tocentral ring 610.

The embodiments shown in FIGS. 6A-6D may also use an engaging member toprovide assistance to device 600 in returning to its contracted memoryshape and/or in retaining its contracted shape. For example, a ring maybe placed over the top of device 600 and slid down arms 620, providingadditional force to contract arms 620.

In some embodiments the devices for reshaping a heart valve of thepresent disclosure may also be covered in Dacron, polyester, or someother biocompatible material. It may be that only a portion of thedevice may be covered, for example, any one or combination of the arms,central ring, linkages, hooks, and slider may be covered.

FIGS. 7A-7D illustrate an example of operation of an example hook, inaccordance with some embodiments of the present disclosure. As shown inFIG. 7A and as described above, at the end of arm 120 is a hook 770. Asshown in FIG. 7A, the profile of hook 770 may be a tapered point of arm120. Additionally, as shown in FIG. 7B, hook 770 may be angled such thatit is positioned to more effectively pierce, penetrate, or otherwiseengage annular tissue. For example, as described above, hook 770 mayform an angle of between approximately forty-five and ninety degreeswith the annular tissue.

As illustrated between FIGS. 7B and 7C, a force may be applied to causehook 770 to pierce, penetrate, or otherwise engage the annular tissue.Once that has occurred, arm 120 may be contracted, as described herein.As illustrated in FIG. 7D, as arm 120 is contracted, hook 770 gathersand draws annular tissue inward with it as arm 120 contracts.Additionally, because of the orientation of hook 770, it may resistwithdrawal from the annular tissue, with the resistance increasing thefurther arm 120 is contracted.

FIGS. 8A-8D illustrate an example of operation of another example hook,in accordance with some embodiments of the present disclosure. As shownin FIG. 8A, at the end of arm 120 is a hook 870. As shown in FIG. 8A,the profile of hook 870 may include a point but may also include scoopson either side of the point. In other words, hook 870 may have a scoopedprofile. These scoops may be shaped such that hook 870 may still be ableto adequately puncture, pierce, or otherwise engage annular tissue. Forexample, hook 870 may be flat but with the profile shown in FIG. 870 .In this way, for example as shown in FIGS. 8B and 8C, arm 120 may beextended and then hook 870 may be forced into the annular tissue. Asshown in comparison of FIGS. 8C to 8D, as arm 120 is contracted, hook870 is able to draw annular tissue inwards with it. When compared to theprofile of hook 770 illustrated in FIG. 7A, the profile of hook 870 ofFIG. 8A may have an increased surface area to catch and draw moreannular tissue inwards as arm 120 contracts. This may be because of thescoops on either side of the point of hook 870.

While two examples of hooks are shown in FIGS. 7A-7D and FIGS. 8A-8D, itwill be appreciated that the hooks of the present disclosure could takeany of a variety of profiles or shapes and are within the scope of thepresent disclosure. For example, as the surface area of a hook isincreased, it will resist contraction of the arm more but will draw moreannular tissue inwards with it. An increase in surface area may alsomake it more difficult for the hook to pierce the annular tissue. As thesurface area decreases, or in other words, as the point becomes morepointed, it may become easier to pierce the annular tissue. However,this may come at a cost that the hook may not draw as much annulartissue with it when the hook's arm contracts.

Additionally, the hooks of the present disclosure may include featuresto resist withdrawal from the annular tissue. For example, they mayinclude barbs, protrusions, or other projections that prevent or resistwithdrawal of the hooks out of the annular tissue. In some embodiments,a portion of the hooks may be sharpened or otherwise configured to morereadily pierce or engage with the annular tissue.

In addition to the profiles of hooks shown in FIGS. 7A-7D and FIGS.8A-8D, other attachment feature may be used to engage the arms with thetissue. By way of non-limiting example, this may include staples,sutures, or barbs to engage the tissue proximate the heart valve.

While hooks 170, hooks 770 and hooks 870 are all shown at an end of theplurality of arms, it is envisioned that an attachment feature,including said hooks, could be placed at any point along a respectivearm. For example, the feature may be placed near the end opposite thepivot point, but not all the way to the end. As another example, theattachment feature may be located approximately half way down the arm.In some embodiments, more than one hook or other attachment feature maybe included on an arm, and may be at more than one location.

This disclosure encompasses all changes, substitutions, variations,alterations, and modifications to the example embodiments herein that aperson having ordinary skill in the art would comprehend. Similarly,where appropriate, the appended claims encompass all changes,substitutions, variations, alterations, and modifications to the exampleembodiments herein that a person having ordinary skill in the art wouldcomprehend. Moreover, reference in the appended claims to an apparatusor system or a component of an apparatus or system being adapted to,arranged to, capable of, configured to, enabled to, operable to, oroperative to perform a particular function encompasses that apparatus,system, component, whether or not it or that particular function isactivated, turned on, or unlocked, as long as that apparatus, system, orcomponent is so adapted, arranged, capable, configured, enabled,operable, or operative. For example, various embodiments may performall, some, or none of the steps described above. Various embodiments mayalso perform the functions described in various orders.

Although the present invention has been described above in connectionwith several embodiments; changes, substitutions, variations,alterations, transformations, and modifications may be suggested to oneskilled in the art, and it is intended that the present inventionencompass such changes, substitutions, variations, alterations,transformations, and modifications as fall within the spirit and scopeof the appended claims.

What is claimed is:
 1. A device for reshaping heart tissue, the devicecomprising: a central ring extending about a central axis; three or morearms pivotably coupled circumferentially about the central ring at arespective first end thereof and each having a tissue-engaging featureat a second end thereof arranged about the central ring to engage tissuein a circumferential configuration; wherein the plurality of arms aremovable about the first ends thereof between a first contractedconfiguration, an expanded configuration radially outwardly of the firstcontracted configuration, and a second contracted configuration radiallyinwardly of the expanded configuration and radially outwardly of thefirst contracted configuration with the tissue-engaging features movingin a radially inwardly circumferential direction to circumferentiallycontract tissue engaged therewith; an expansion device, positioned withrespect to the plurality of arms to move the plurality of arms betweenthe first contracted configuration, the expanded configuration, and thesecond contracted configuration to circumferentially contract tissueengaged with the tissue-engaging features of the plurality of arms; andan engaging member disposed over at least two arms of the plurality ofarms to retain the plurality of arms in the second contractedconfiguration.
 2. The device of claim 1, further comprising a cap toprevent the three or more arms from extending beyond approximatelyninety degrees with the central axis.
 3. The device of claim 1, whereinthe expansion device further comprises: a slider slidable along thecentral axis relative to the central ring; and a plurality of linkages,each of the plurality of linkages coupled to the slider and coupled to arespective arm of the three or more arms to facilitate the movement ofthe three or more arms.
 4. The device of claim 1, wherein the centralring is a unitary body with the three or more arms.
 5. The device ofclaim 4, wherein the device is made of a shape memory material, and thethree or more arms contract to the first contracted configuration and/orthe second contracted configuration due to the shape memory material ofthe device.
 6. The device of claim 1, wherein the three or more armsincludes a groove, notch, or combination thereof configured to settlethe engaging member following advancement of the engaging member overthe three or more arms.
 7. The device of claim 6, wherein the engagingmember is advanced to increase a contraction of the three or more armsbeyond the second contracted configuration.
 8. The device of claim 1,wherein at least two attachment features are oriented differently withrespect to each other such that different force vectors are resisted byat least two attachment features.
 9. The device of claim 1, wherein theattachment feature is a hook with a scooped profile.
 10. The device ofclaim 9, wherein the three or more arms are configured forcircumferential attachment to annular tissue, wherein an angle of thehook relative to the annular tissue when the three or more arms are inthe expanded configuration ranges between forty-five and ninety degrees.11. The device of claim 1, wherein the three or more arms arecontractable such that the three or more arms are substantially parallelwith the central axis.
 12. The device of claim 1, wherein at least aportion of the device is covered with a biocompatible material.
 13. Adevice for reshaping heart tissue, the device comprising: a central ringextending about a central axis; three or more arms pivotably coupledcircumferentially about the central ring at a respective first endthereof and each having a tissue-engaging feature at a second endthereof arranged about the central ring to engage tissue in acircumferential configuration; and a slider slidable along the centralaxis relative to the central ring and coupled to a respective arm of thethree or more arms to apply a force to the inside of the three or morearms to move the three or more arms between a first contractedconfiguration, an expanded configuration radially outwardly of the firstcontracted configuration, and a second contracted configuration radiallyinwardly of the expanded configuration to circumferentially contracttissue engaged with the tissue-engaging features of the plurality ofarms and radially outwardly of the first contracted configuration. 14.The device of claim 13, wherein the device is positionable around aheart valve and the second contracted configuration reduces acircumference of the heart valve.
 15. The device of claim 13, whereinthe central ring is a unitary body with the three or more arms.
 16. Thedevice of claim 13, wherein the device is made of a shape memorymaterial and the three or more arms contract due to the shape memorymaterial of the device.
 17. The device of claim 13, wherein at least twoattachment features are oriented differently with respect to each othersuch that different force vectors are resisted by at least twoattachment features.
 18. The device of claim 9, wherein the three ormore arms are configured for attachment to annular tissue, and an angleof the hook relative to the annular tissue when the three or more armsare in the expanded configuration ranges between forty-five and ninetydegrees.
 19. The device of claim 13, wherein the three or more arms arecontractable such that the three or more arms are substantially parallelwith the central axis and the device may be disposed within a deliverycatheter.
 20. A system comprising: a delivery catheter; a delivery shaftdisposed within the delivery catheter; a device for delivery by thedelivery catheter and removably coupled to the delivery shaft, thedevice comprising: a central ring about a central axis; three or morearms coupled to the central ring, each of the arms pivotably coupledcircumferentially about the central ring at a pivot point at a first endof the arm, each of the arms comprising tissue-engaging feature at asecond end of the arm; and a slider slidable along the central axisrelative to the central ring and coupled to a respective arm of thethree or more arms to facilitate the movement of the three or more armsbetween a first contracted configuration, an expanded configuration, anda second contracted configuration to circumferentially contract tissueengaged with the tissue-engaging features of the plurality of arms.